[Preliminary establishment of quantitative detection for luteinizing hormone based on superparamagnetic particles labeled immuno chromatography method].

OBJECTIVE:To develop a quick quantitative detecting method for luteinizing hormone(LH) based on superparamagnetic particles labeled immunochromatography technology. METHODS:Magnetic particles were catalyzed by EDC/NHS, LH monoclonal antibody were coupled with magnetic particles, another antibody were coated with the NC membrane, established a quantitative detecting method combined sand wish assay format with immunochromatography. The performance of this method was evaluated by linear range, precision, accuracy, specificity and stability. Detecting the serum sample that were tested by chemiluminescence immunoassay (CLIA) which was high credibility to verify the reliability. RESULTS:The reaction time of LH antibody coupled magnetic particles, LH and LH antibody coated in nitrocellulose membrane was 20 min; the coefficient of variation (CV) values for low, median, high were 8%-12%, the bias was less than 10%, recovery rate was 90%-120%, the minimum detection limit was 0.63 mIU/ml, no obvious cross reaction with human chorionic gonadotropin (HCG), thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH). Test results of clinical sample had good correlation with CLIA (R² =0.96, P<0.05). CONCLUSION:The superparamagnetic particles labeled immuno-chromatography method is simple and rapid, and is expected to become a direction in the development for point-of-care test (POCT) quantitative detection of micro components in biological sample.